CTRI/2021/07/034990
尚未招募
2 期
Primary Surgery versus Primary Chemoradiation for Oropharyngeal Cancer (SCOPe trial) â??A Phase II/III Integrated Design Randomized Control Trial. - SCOPe
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Tata Memorial Centre
- 状态
- 尚未招募
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Histopathology proven diagnosis of squamous cell carcinoma of the oropharynx, localized to the tonsil and /or lateralized tongue\-base
- •2\. ECOG Performance Status \<\=2
- •3\. Age \>\=18 to 70 years
- •4\. Anesthetic fitness obtained for surgery under general anesthesia
- •5\. Resectable primary tumor with an anticipation of achieving resection free margins either by minimally invasive/open techniques
- •6\. Clinical stage III or IV, i.e. T1 T2 or T3 \-T4 with N0\-N3\.
- •Nodal disease with extranodal extension on clinical examination/
- •imaging may be included at the surgeonâ??s discretion, if the nodal disease is deemed resectable by the operating surgeon
- •7\. HPV negative status determined by p16 status
- •8\. No distant metastases below the clavicles, based upon the following minimum
排除标准
- •1\. Prior head and neck malignancy
- •2\. Prior invasive malignancy, unless disease free for a minimum of 3 years
- •3\. Prior chemotherapy for a different cancer administered
- •within 3 years prior to registration
- •4\. Patients who have received any neoadjuvant/ induction chemotherapy
- •5\. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation therapy fields
- •6\. Unresectable primary or nodal disease involving the carotid vessels, prevertebral fascia or skull base
- •7\. Large soft palate involvement \>1 cm 8\. Deep extension into larynx,
- •pre\-epiglottic space and deep invasion into extrinsic
- •muscles of tongue
结局指标
主要结局
未指定
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